Body Temperature, ECG, Oxygen Saturation, Respiration
Conditions
Brief summary
This is an observational, cohort-based, single-site, prospective study conducted in accordance with ISO 14155-1:2003 and ISO 14155-1:2011. The primary objectives are to evaluate the accuracy of the device's measurements/readings in comparison to a gold standard or standard of care patient monitor.
Detailed description
This is an observational, cohort-based, single-site, prospective clinical study enrolling up to 100 patients who are hospitalized in the internal ward. There is no control group. The primary objectives of the study are: 1. Evaluate the body temperature measured by the ear unit and validate its accuracy. 2. Evaluate the accuracy of SPO2 signals and results by comparing the readings to a gold standard device with a finger sensor. 3. Evaluate the ECG and respiration signals recorded by the patch device by comparing them to the signals recorded by a patient monitor with standard leads. The secondary objectives of the study are: 4. Usability - evaluate the ease of use of the device by medical staff and patients (e.g., positioning, activation, replacement of patch, understanding processes and requirements). 5. Evaluate the signals quality and the patch adherence after 5 - 7 days on the chest. The study will assess the safety and effectiveness of the Vital Signs Monitoring System (VSMS) for its intended use/proposed indications. Data will be collected while the VSMS is adhered to each patient for the entire hospitalization period, up to 7 days. There is no follow-up required.
Interventions
DEVICEVital Signs Monitoring System
The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
Sponsors
G Medical Innovations Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Signed written informed consent * Age above 18 years from both genders * American Society of Anesthesiologists (ASA) physical status classification of 1-4 * Hospitalized in internal ward
Exclusion criteria
* Abuse of alcohol or illicit drugs * History of mental retardation or any mental disease * Skin irritation / Atopic dermatitis or any other skin condition in the area of patient's upper chest that might affect his/her ability to adhere the device appropriately
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Temperature measured in units of Celsius/Fahrenheit | 6-10 days | Validation of measurement accuracy of skin temperature as compared to gold standard. |
| Oxygen Saturation measured in units of percentage peripheral saturated oxygen | 6-10 days | Validation of measurement accuracy of peripheral oxygen saturation as compared to gold standard. |
| .ECG signal recording and Respiration measured in units heart beat per minute | 6-10 days | Assess quality of device's recorded ECG and respiration signals as compared to patient monitor with standard leads |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of recorded signal | after 5-7 days of device usage | Evaluate the quality of recorded signals in time by comparing signal of day 1 with signal in last day of adherence of the patch |
Countries
Israel
Contacts
Primary ContactAnat Alon
Backup ContactPeter Spiegel
Outcome results
None listed